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Completed

NCT Number: NCT00943917

Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to determine safety, efficacy and tolerability of various doses of ITCA 650 in subjects with type 2 diabetes.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Study Site, Chino, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females age 18-70 years
  • Type 2 diabetes mellitus for ≥ 6 months prior to Screening Visit 1
  • On a stable (> 3 months prior to Screening Visit 1) treatment regimen of metformin monotherapy;
  • Fasting plasma glucose < 240 mg/dL at Screening Visit 1
  • HbA1c ≥ 7% and ≤ 10% at Screening Visit 1

Exclusion criteria

  • Prior treatment with exenatide
  • Treatment with any of the following antidiabetic agents within 3 months prior to Screening Visit 1: TZDs, sulfonylureas, DPP IV inhibitors, acarbose, or insulin (injected or inhaled)
  • History of type 1 diabetes and/or history of diabetic ketoacidosis
  • Body mass index ≥ 40 kg/m2;
  • History of organ transplantation

Treatment and study plan

ITCA 650

Other

ITCA 650 (continuous delivery of exenatide in DUROS)

exenatide injection

Drug

twice daily (BID) injections of exenatide commercially available Byetta: 5 mcg/dose first 12 weeks then 10 mcg/dose for 8 weeks

Other names: Byetta

Ex Inj/ITCA 650

Other

twice-daily (BID) exenatide injection: 5 mcg/dose for 4 weeks then 10 mcg/dose for 8 weeks, followed by ITCA 650

Other names: Byetta

Primary outcomes

  1. Mean Change in HbA1c (Per Protocol)

    Time frame: Day 0 and Week 12

    Mean change in HbA1c over first 12 weeks (Stage I)

  2. Mean Change in HbA1c (ITT)

    Time frame: Day 0 to Week 12

    Mean change in HbA1c through Week 12

  3. Mean Change in HbA1c (Per Protocol)

    Time frame: Day 0 to Week 24

    Mean change in HbA1c through Week 24

  4. Mean Change in HbA1c (ITT)

    Time frame: Day 0 to Week 24

    Mean change in HbA1c through Week 24

  5. Mean Change in HbA1c (Per Protocol)

    Time frame: Day 0 to Week 48

    Mean change in HbA1c through Week 48

  6. Mean Change in HbA1c (ITT)

    Time frame: Day 0 to Week 48

    Mean change in HbA1c through Week 48

Sponsors and collaborators

Lead sponsor

Intarcia Therapeutics

Industry

Registry information

Official study title

Phase 2 Study of ITCA 650 in Subjects With Type 2 Diabetes Mellitus

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jul 22, 2009
Registry last updated
Apr 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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